Compliance Monitor

Regulatory landscapes change constantly. A new FDA guidance document, an updated EMA IVDR rule, or an ANVISA RDC amendment can invalidate sections of your dossier overnight. The Compliance Monitor scrapes all four regulatory agencies daily and runs each publication through your project's regulatory profile to determine whether it affects you — and how urgently.

How it works

1. Daily Scraping ANVISA DOU, FDA Federal Register and guidance documents, EMA EUDAMED updates, and Health Canada notices are scraped every 24 hours.
2. Project Matching Each publication is matched against your project's product class, regulatory pathway, and submission sections. Only relevant updates trigger alerts.
3. Impact Scoring Alerts are scored 0–100 for urgency: mandatory rules score 75–90, recalls score 90–100, guidance documents score 50–70. You see what needs immediate attention.
4. Notification & Action Alerts appear in your project dashboard and are sent by email. Each alert links to the affected dossier section with a recommendation for how to address it.

What you get

• Daily scraping: ANVISA DOU, FDA Federal Register, EMA EUDAMED, Health Canada
• Project-specific matching — only relevant alerts reach you
• Urgency scoring 0–100 (recall > mandatory rule > guidance > notice)
• Dossier section linking — each alert maps to the affected section
• Email notifications with configurable frequency
• Alert history and audit log
• ICH-GCP updates for clinical trial compliance

Who it is for

• Regulatory affairs professionals with active submissions in review
• Teams managing post-market surveillance obligations
• Quality managers responsible for design history file currency
• CROs managing client dossiers across multiple jurisdictions
• Startups tracking FDA guidance for their product category